A Beta-only IL-2 ImmunoTherapY (ABILITY) Study

Titre officiel

A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumours

Sommaire:

This is a Phase 1/2, multi-centre, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumour activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumours.

Description de l'essai

Primary Outcome:

• Recommended Phase 2 Dose (RP2D) for MDNA11
• Incidence of Treatment Related Adverse Events (TRAEs)
• Incidence of Treatment Emergent Adverse Events (TEAEs)

Secondary Outcome:

• Pharmacokinetic characteristics on MDNA11 - Cmax (ug/mL)
• Pharmacokinetic characteristics on MDNA11 - Tmax (h)
• Pharmacokinetic characteristics on MDNA11 - AUClast (h.ug/mL)
• Pharmacodynamic effects of MDNA11
• Anti-tumour activity of MDNA11 (alone or in combination with CPI) - Overall Response Rate (ORR)
• Anti-tumour activity of MDNA11 (alone or in combination with CPI) - Disease Control Rate (DCR)
• Anti-tumour activity of MDNA11 (alone or in combination with CPI) - Progression Free Survival (PFS)

The study drug, MDNA11, is a selective IL-2 preferentially activating effector T cells (naïve CD8+ T-cells) and NK cells responsible for killing cancer cells, with minimal or no stimulation of the immunosuppressive Tregs. It is designed to potentially enhance host immune response and fusion to albumin increases the half-life further avoiding frequent dosing required with rhIL-2.

The study will be conducted at approximately 12 clinical sites following regulatory authority and institutional review board / independent ethics committee (IRB/ IEC) approval and completion of informed consent. The study will be conducted in two parts:

• Sequential Dose Escalation
• Dose Expansion in monotherapy as well as with an immune checkpoint inhibitor.

Approximately 80 patients will be enrolled.

Tumour assessment by CT/MRI will be performed every 12 weeks and will continue until documented disease progression. Treatment may continue for up to 1 year, or until treatment discontinuation criteria are met. Patients can withdraw from participation at any time.

Voir cet essai sur ClinicalTrials.gov